Vaginal Surgery
Conditions
Keywords
Belladonna, Morphine, Suppositories, Vaginal, Surgery, Postoperative, Pain
Brief summary
Our primary aim is to determine whether the routine use of belladonna and morphine suppositories will improve pain control following vaginal surgery. Treatment will begin immediately following surgery and every 8 hours for 16 hours.
Detailed description
Minimizing postoperative pain is vital to a successful surgical recovery. Inadequate pain control may result in nausea, vomiting, an extended hospital stay, and reduced patient satisfaction. Oral and parenteral narcotics are commonly used for pain relief and their use may exacerbate the incidence of sedation, nausea, and vomiting; ultimately delaying convalescence. Previous studies have demonstrated that rectal analgesia following surgery results in lower pain scores and less intravenous morphine consumption. Belladonna and opium suppositories are routinely prescribed at our institution and their efficacy has not been confirmed. A prospective, randomized, double-blind, placebo-controlled trial will be undertaken using belladonna and opium rectal suppositories following vaginal surgery. Treatment will begin immediately following surgery and continue every 8 hours for a total of 3 doses.
Interventions
DRUGBelladonna and Opium Suppositories
Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Sponsors
Kristina A. Butler
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for elective vaginal surgery requiring general anesthesia at the Mayo Clinic Hospital. This would include a vaginal hysterectomy with culdoplasty or post-hysterectomy prolapse repair, including culdoplasty with or without anterior/posterior repair.
Exclusion criteria
* Participation in another trial using an investigational product. * Pregnancy. * Scheduled for a non-vaginal surgical procedure. * Scheduled for a robotic hysterectomy. * Scheduled to have combined surgeries (vaginal surgery plus another non-vaginal surgery). * There is a known hypersensitivity to belladonna and/or opium. * Contraindication to narcotic use. * Chronic pain with preoperative pain score greater than 4 out of 10 points. * Clinically significant substance abuse. * Mental condition that may impair the ability to provide study assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at Hour 4 | 4 hours following surgery | Pain at 4 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain at Hour 20 | 20 hours after surgery. | Pain at 20 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable. |
| Narcotic Rescue Medication | For 24 hours following surgery | Use of all ancillary narcotic medications was taken from the medical record. |
| Number of Subjects With Nausea | Approximately 12 hours after surgery | This information was taken from the medical record. |
| Pain at Hour 12 | 12 hours after surgery. | Pain at 12 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable. |
| Number of Times Antiemetic Rescue Medication Was Used | First 24 hours after surgery | — |
| Number of Subjects Who Used Antiemetic Rescue Medications | First 24 hours after surgery | — |
| Satisfaction With Pain Relief | Approximately 24 hours following surgery | Patient satisfaction with pain relief was evaluated 24 hours after surgery using a linear analog satisfaction scale, with 0 being very dissatisfied, and 10 being very satisfied. |
| Number of Subjects With Vomiting | Within 20 hours of surgery | This information was taken from the medical record. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited at the Mayo Clinic in Arizona, United States from January 2011 to April 2013.
Participants by arm
| Arm | Count |
|---|---|
| Belladonna and Opium Suppositories Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. | 41 |
| Placebo Suppositories Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. | 49 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cancer found | 1 | 0 |
| Overall Study | Drug did not arrive in time | 1 | 0 |
| Overall Study | Drug not administered | 1 | 0 |
| Overall Study | Multiple Studies | 0 | 1 |
| Overall Study | Rectotomy | 1 | 0 |
| Overall Study | Surgery Changed | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 2 |
Baseline characteristics
| Characteristic | Belladonna and Opium Suppositories | Placebo Suppositories | Total |
|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 12 | 55 years STANDARD_DEVIATION 13 | 55 years STANDARD_DEVIATION 12.5 |
| Estimated Blood Loss | 180 mL STANDARD_DEVIATION 250 | 150 mL STANDARD_DEVIATION 110 | 161 mL STANDARD_DEVIATION 186 |
| Pelvic Organ Prolapse No Prolapse | 20 participants | 24 participants | 44 participants |
| Pelvic Organ Prolapse Prolapse | 21 participants | 25 participants | 46 participants |
| Preoperative Pain | 0.44 units on a scale STANDARD_DEVIATION 1.25 | 0.24 units on a scale STANDARD_DEVIATION 0.91 | 0.3 units on a scale STANDARD_DEVIATION 1.07 |
| Procedure time | 98 minutes STANDARD_DEVIATION 37 | 96 minutes STANDARD_DEVIATION 38 | 97 minutes STANDARD_DEVIATION 37 |
| Region of Enrollment United States | 41 participants | 49 participants | 90 participants |
| Sex: Female, Male Female | 41 Participants | 49 Participants | 90 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 41 | 27 / 49 |
| serious Total, serious adverse events | 1 / 41 | 0 / 49 |
Outcome results
Primary
Pain at Hour 4
Pain at 4 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable.
Time frame: 4 hours following surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belladonna and Opium Suppositories | Pain at Hour 4 | 4.2 units on a scale | Standard Deviation 2.4 |
| Placebo Suppositories | Pain at Hour 4 | 4.1 units on a scale | Standard Deviation 2.1 |
p-value: 0.82t-test, 2 sided
Secondary
Narcotic Rescue Medication
Use of all ancillary narcotic medications was taken from the medical record.
Time frame: For 24 hours following surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belladonna and Opium Suppositories | Narcotic Rescue Medication | 57 mg IV morphine equivalents | Standard Deviation 38 |
| Placebo Suppositories | Narcotic Rescue Medication | 66 mg IV morphine equivalents | Standard Deviation 61 |
p-value: 0.43t-test, 2 sided
Secondary
Number of Subjects Who Used Antiemetic Rescue Medications
Time frame: First 24 hours after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belladonna and Opium Suppositories | Number of Subjects Who Used Antiemetic Rescue Medications | 30 participants |
| Placebo Suppositories | Number of Subjects Who Used Antiemetic Rescue Medications | 33 participants |
p-value: 0.55t-test, 2 sided
Secondary
Number of Subjects With Nausea
This information was taken from the medical record.
Time frame: Approximately 12 hours after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belladonna and Opium Suppositories | Number of Subjects With Nausea | 14 participants |
| Placebo Suppositories | Number of Subjects With Nausea | 22 participants |
p-value: 0.3t-test, 2 sided
Secondary
Number of Subjects With Vomiting
This information was taken from the medical record.
Time frame: Within 20 hours of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belladonna and Opium Suppositories | Number of Subjects With Vomiting | 13 participants |
| Placebo Suppositories | Number of Subjects With Vomiting | 9 participants |
p-value: 0.14t-test, 2 sided
Secondary
Number of Times Antiemetic Rescue Medication Was Used
Time frame: First 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belladonna and Opium Suppositories | Number of Times Antiemetic Rescue Medication Was Used | 1.7 number of times antiemetics used | Standard Deviation 1.6 |
| Placebo Suppositories | Number of Times Antiemetic Rescue Medication Was Used | 1.6 number of times antiemetics used | Standard Deviation 1.5 |
p-value: 0.83t-test, 2 sided
Secondary
Pain at Hour 12
Pain at 12 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable.
Time frame: 12 hours after surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belladonna and Opium Suppositories | Pain at Hour 12 | 3.4 units on a scale | Standard Deviation 2.4 |
| Placebo Suppositories | Pain at Hour 12 | 3.3 units on a scale | Standard Deviation 2.2 |
p-value: 0.75t-test, 2 sided
Secondary
Pain at Hour 20
Pain at 20 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable.
Time frame: 20 hours after surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belladonna and Opium Suppositories | Pain at Hour 20 | 2.5 units on a scale | Standard Deviation 1.9 |
| Placebo Suppositories | Pain at Hour 20 | 3.4 units on a scale | Standard Deviation 2.5 |
p-value: 0.07t-test, 2 sided
Secondary
Satisfaction With Pain Relief
Patient satisfaction with pain relief was evaluated 24 hours after surgery using a linear analog satisfaction scale, with 0 being very dissatisfied, and 10 being very satisfied.
Time frame: Approximately 24 hours following surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Belladonna and Opium Suppositories | Satisfaction With Pain Relief | 8.2 units on a scale | Standard Deviation 2.5 |
| Placebo Suppositories | Satisfaction With Pain Relief | 7.9 units on a scale | Standard Deviation 2.6 |
p-value: 0.59t-test, 2 sided